Project Manager - GMP/GLP Small Molecule Liaison

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

For this position you will have these job responsibilities:

• Monitor external project activates, manage book-of-work, facilitate and/or lead project progress meetings with contract research organizations (CROs), perform issue resolution and escalations and complete project close out activities.

• Liaise between development scientists and CROs.

• Ensure that CROs follow applicable SOPs and Quality Agreements.

• Ensure compliance with and maintain required training in relevant Clientand departmental GMP, GLP, SOP, safety and other guidelines.

• Manage and Maintain documents and records electronically in DocMan system according to SOPs.

• Support Infinity investigations.

• Manage EASM Sharepoint site by understanding EASM’s collaboration, workflow, data and document management requirements and opportunities, review existing Sharepoint infrastructure, and provide improvement solutions in order to maximize the efficiency and capability.

• Contribute to EASM and ASO continuous improvement initiatives.

• Collaborate with internal and external partners.

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

PPDFSP

*LI-SW1

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

For this position you will have these job responsibilities:

• Monitor external project activates, manage book-of-work, facilitate and/or lead project progress meetings with contract research organizations (CROs), perform issue resolution and escalations and complete project close out activities.

• Liaise between development scientists and CROs.

• Ensure that CROs follow applicable SOPs and Quality Agreements.

• Ensure compliance with and maintain required training in relevant Clientand departmental GMP, GLP, SOP, safety and other guidelines.

• Manage and Maintain documents and records electronically in DocMan system according to SOPs.

• Support Infinity investigations.

• Manage EASM Sharepoint site by understanding EASM’s collaboration, workflow, data and document management requirements and opportunities, review existing Sharepoint infrastructure, and provide improvement solutions in order to maximize the efficiency and capability.

• Contribute to EASM and ASO continuous improvement initiatives.

• Collaborate with internal and external partners.

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

PPDFSP

*LI-SW1

Education and Experience: 

Bachelor's degree in Chemistry, Pharaceutical Cience or related field or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

Knowledge, Skills and Abilities:

Must have proven technical expertise in analytical chemistry techniques and analytical method development and validation. It is preferred that the FTE consultant have prior experience with Sharepoint site management. At least one year of experience with GMP and/or GLP is required. Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote). Strong project management, organizational and communication skills are needed. The ability to work independently and as part of a team in a cross-functional environment is also required. Sound interpersonal skills, is flexible and adapts to changing situations Ability to persuade, convince, and influence or impress others Organized, proficient at multitasking with good attention to detail Ability to effectively prioritizes workload Ability to be a self-starter who works independently and will take initiative.

Working Environment: 

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.  

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

Education and Experience: 

Bachelor's degree in Chemistry, Pharaceutical Cience or related field or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

Knowledge, Skills and Abilities:

Must have proven technical expertise in analytical chemistry techniques and analytical method development and validation. It is preferred that the FTE consultant have prior experience with Sharepoint site management. At least one year of experience with GMP and/or GLP is required. Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote). Strong project management, organizational and communication skills are needed. The ability to work independently and as part of a team in a cross-functional environment is also required. Sound interpersonal skills, is flexible and adapts to changing situations Ability to persuade, convince, and influence or impress others Organized, proficient at multitasking with good attention to detail Ability to effectively prioritizes workload Ability to be a self-starter who works independently and will take initiative.

Working Environment: 

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.  

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.